Home Versus Hospital Based Action Observation Therapy in Diaplegic Cerebral Palsy

NCT ID: NCT05586191

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2023-02-15

Brief Summary

Effects of Home Versus Hospital Based Action Observation Therapy on Balance, Mobility and Cognition in Diaplegic Cerebral Palsy. It will be a RCT we want to identify the effects of action observation therapy on patients coming to the hospital as compared to the patients at home. We will also identify the retaining effects of AOT. Our sample size will be 40 diplegic patients having no cognitive issues and able to walk with assistive device. We will exclude the patient who will suffer with severe comorbidities and visual impairment. We will randomly assign the patients into two groups A and B.A will receive Action observation therapy three times a day along with stretching exercises .while group B we perform AOT and stretching exercises at home with same frequency.

Conditions

Diplegic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Action Observation therapy at home

In action observation therapy, patient will not come to hospital for treatment. He will see a video at home in which therapist will perform different activities then patient will also perform the same movements.

Group Type: EXPERIMENTAL

Action observation at home

Intervention Type: OTHER

Exercises included will contain four stages of exercises. Each stage will be followed for 2 weeks i.e. stage 1 for 1st and 2nd week, second stage for 3rd and 4th week, third stage for 5th and 6th week and fourth stage for 7th and 8th week of treatment. Each component of every stage will be played for 1 minute in front of participants, followed by 1 minute rest and then these exercises will be performed for 5 minutes.

All participants will perform AOT 3 times/week for up to 8 weeks along with functional training for the rest of the weeks. Functional training will include stretching and isometric exercises (stretching of hamstring and calf muscle while quads isometric). Assessment will be done by using the tools at baseline and after 8 weeks of intervention. A final reading will be taken after 12 weeks to check the maintenance of training effects.

Action Observation therapy at hospital

In action observation therapy, patient will come to hospital for treatment. He will see a video in which therapist will perform different activities then patient will also perform the same movements.

Group Type: ACTIVE_COMPARATOR

Action Observation therapy at hospital

Intervention Type: OTHER

Exercises included will contain four stages of exercises. Each stage will be followed for 2 weeks i.e. stage 1 for 1st and 2nd week, second stage for 3rd and 4th week, third stage for 5th and 6th week and fourth stage for 7th and 8th week of treatment. Each component of every stage will be played for 1 minute in front of participants, followed by 1 minute rest and then these exercises will be performed for 5 minutes.

All participants will perform AOT 3 times/week for up to 8 weeks along with functional training for the rest of the weeks. Functional training will include stretching and isometric exercises (stretching of hamstring and calf muscle while quads isometric). Assessment will be done by using the tools at baseline and after 8 weeks of intervention. A final reading will be taken after 12 weeks to check the maintenance of training effects.

Interventions

Action observation at home

Exercises included will contain four stages of exercises. Each stage will be followed for 2 weeks i.e. stage 1 for 1st and 2nd week, second stage for 3rd and 4th week, third stage for 5th and 6th week and fourth stage for 7th and 8th week of treatment. Each component of every stage will be played for 1 minute in front of participants, followed by 1 minute rest and then these exercises will be performed for 5 minutes.

All participants will perform AOT 3 times/week for up to 8 weeks along with functional training for the rest of the weeks. Functional training will include stretching and isometric exercises (stretching of hamstring and calf muscle while quads isometric). Assessment will be done by using the tools at baseline and after 8 weeks of intervention. A final reading will be taken after 12 weeks to check the maintenance of training effects.

Intervention Type: OTHER

Action Observation therapy at hospital

Exercises included will contain four stages of exercises. Each stage will be followed for 2 weeks i.e. stage 1 for 1st and 2nd week, second stage for 3rd and 4th week, third stage for 5th and 6th week and fourth stage for 7th and 8th week of treatment. Each component of every stage will be played for 1 minute in front of participants, followed by 1 minute rest and then these exercises will be performed for 5 minutes.

All participants will perform AOT 3 times/week for up to 8 weeks along with functional training for the rest of the weeks. Functional training will include stretching and isometric exercises (stretching of hamstring and calf muscle while quads isometric). Assessment will be done by using the tools at baseline and after 8 weeks of intervention. A final reading will be taken after 12 weeks to check the maintenance of training effects.

Intervention Type: OTHER

Other Intervention Names

stretching exercises of lower limb; stretching exercises of lower limb

Eligibility Criteria

Inclusion Criteria

• Participants falling in this category will be recruited into the study.

• Diagnosed Diaplegic CP Children between the age of 5 to 11 years.
• Without visual impairment and visual field defects.
• Able to follow the researcher's instruction.
• GMFCS (gross motor function classification system) level I-III.

Exclusion Criteria

• Participants failing to fall in this category will be excluded of the study.

• Children with a Modified Ashworth scale (MAS) of 3 or more
• Unable to walk
• Children with severe co-morbidities. (2)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayesha Bashir, MSNMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Irfan General Hospital Peshawar

Peshawar, Khyberpakhtunkhuwa, Pakistan

Countries

Pakistan

References

Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064.

Reference Type: BACKGROUND

PMID: 32570855 (View on PubMed)

Numanoglu A, Gunel MK. Intraobserver reliability of modified Ashworth scale and modified Tardieu scale in the assessment of spasticity in children with cerebral palsy. Acta Orthop Traumatol Turc. 2012;46(3):196-200. doi: 10.3944/aott.2012.2697.

Reference Type: BACKGROUND

PMID: 22659636 (View on PubMed)

Kim Y, Lee BH. Clinical Usefulness of Child-centered Task-oriented Training on Balance Ability in Cerebral Palsy. J Phys Ther Sci. 2013 Aug;25(8):947-51. doi: 10.1589/jpts.25.947. Epub 2013 Sep 20.

Reference Type: BACKGROUND

PMID: 24259891 (View on PubMed)

Reid SM, Carlin JB, Reddihough DS. Distribution of motor types in cerebral palsy: how do registry data compare? Dev Med Child Neurol. 2011 Mar;53(3):233-8. doi: 10.1111/j.1469-8749.2010.03844.x. Epub 2010 Dec 17.

Reference Type: BACKGROUND

PMID: 21166669 (View on PubMed)

Joung HJ, Park J, Ahn J, Park MS, Lee Y. Effects of creative dance-based exercise on gait performance in adolescents with cerebral palsy. J Exerc Rehabil. 2020 Aug 25;16(4):332-343. doi: 10.12965/jer.2040384.192. eCollection 2020 Aug.

Reference Type: BACKGROUND

PMID: 32913838 (View on PubMed)

Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.

Reference Type: BACKGROUND

PMID: 23346889 (View on PubMed)

Park EC, Hwangbo G. The effects of action observation gait training on the static balance and walking ability of stroke patients. J Phys Ther Sci. 2015 Feb;27(2):341-4. doi: 10.1589/jpts.27.341. Epub 2015 Feb 17.

Reference Type: BACKGROUND

PMID: 25729163 (View on PubMed)

Ryan D, Fullen B, Rio E, Segurado R, Stokes D, O'Sullivan C. Effect of Action Observation Therapy in the Rehabilitation of Neurologic and Musculoskeletal Conditions: A Systematic Review. Arch Rehabil Res Clin Transl. 2021 Jan 27;3(1):100106. doi: 10.1016/j.arrct.2021.100106. eCollection 2021 Mar.

Reference Type: BACKGROUND

PMID: 33778479 (View on PubMed)

Other Identifiers

HADIA HADI REC 01335

Identifier Type: -

Identifier Source: org_study_id